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Effect of high-dose postoperative dexamethasone on pain and recovery after total knee and hip arthroplasty
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注册号:

Registration number:

ChiCTR-INR-16007863 

最近更新日期:

Date of Last Refreshed on:

2018-01-25 

注册时间:

Date of Registration:

2016-01-30 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

髋膝关节置换术后高剂量地塞米松对疼痛和快速康复的影响 

Public title:

Effect of high-dose postoperative dexamethasone on pain and recovery after total knee and hip arthroplasty 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

髋膝关节置换术后高剂量地塞米松对疼痛和快速康复的影响 

Scientific title:

Effect of high-dose postoperative dexamethasone on pain and recovery after total knee and hip arthroplasty 

研究课题代号(代码):

Study subject ID:

 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

李金龙 

研究负责人:

周宗科 

Applicant:

Li Jinlong 

Study leader:

Zhou Zongke 

申请注册联系人电话:

Applicant telephone:

+86 18040350096 

研究负责人电话:

Study leader's telephone:

+86 18980601028 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

476825891@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

zongke@126.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

四川省成都市武侯区国学巷37号 

研究负责人通讯地址:

四川省成都市武侯区国学巷37号 

Applicant address:

37 Guoxuexiang, Chengdu, Sichuan, China  

Study leader's address:

37 Guoxuexiang, Chengdu, Sichuan, China  

申请注册联系人邮政编码:

Applicant postcode:

610041 

研究负责人邮政编码:

Study leader's postcode:

610041 

申请人所在单位:

四川大学华西医院骨科 

Applicant's institution:

Department of Orthopaedics, West China Hospital, Sichuan University 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

2012-268 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

四川大学华西医院临床试验与生物医学伦理专委会  

Name of the ethic committee:

Clinical Research and Biomedical Ethical Committee of West China hospital, Sichuan University  

伦理委员会批准日期:

Date of approved by ethic committee:

2013-01-07 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

四川大学华西医院骨科 

Primary sponsor:

Department of Orthopaedics, West China Hospital, Sichuan University  

研究实施负责(组长)单位地址:

四川省成都市武侯区国学巷37号 

Primary sponsor's address:

37 Guoxuexiang, Chengdu, Sichuan, China  

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

四川

市(区县):

成都

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

华西医院

具体地址:

四川省成都市武侯区国学巷37号

Institution
hospital:

West China Hospital

Address:

37 Guoxuexiang, Chengdu, Sichuan, China

经费或物资来源:

卫生部行业科研专项基金 

Source(s) of funding:

Ministry of Health Special Scientific Research Projects of China  

研究疾病:

髋/膝关节原发性骨关节炎 

Target disease:

Hip/knee osteoarthritis 

研究疾病代码:

Target disease code:

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

评估术后大剂量应用地塞米松用于初次髋膝关节置换术后减轻术后疼痛,抑制炎症反应,加速功能锻炼. 

Objectives of Study:

This study was desgnied to evaluate the application of a high dose of dexamethasone after total knee and hip arthroplasty in reducing postoperative pain, inhibiting inflammation, and speeding early knee function. 

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1.初次、单侧全膝关节置换术;2.膝关节原发性骨关节炎患者;3. 术前IL-1、IL-6、CRP、TNF、ESR、NEUT指标正常; 4.能够并愿意签署知情同意书  

Inclusion criteria

1. Primary unilateral total knee artropasty; 2. Patients with Knee osteoartritis; 3. Able and willing to provide signed informed consent; 4. the level of IL-1, IL-6, CRP, TNF, ESR, NEUT are normal before surgery.  

排除标准:

1.双膝关节一期手术或膝关节翻修术; 2.膝关节既往手术史; 3.近三月内做过膝关节穿刺; 4.膝关节僵直; 5.血液凝固障碍性疾病; 6.下肢深静脉血栓病史; 7.无法控制的高血压、严重的心血管疾病、心衰、慢性阻塞性肺炎、肝肾衰竭等严重的伴随疾病; 8.既往地塞米松及肾上腺皮质激素类药物过敏史者; 9. 近6个月有过肾上腺皮质激素治疗史者 

Exclusion criteria:

1. Simultaneously bilateral total knee artropasty or revision case; 2. Surgical History of the knee joint; 3. Knee joint cavity paracentesis in recent 3 months; 4. Stiffness with knee; 5. Blood coagulation disorders; 6. History of deep venous thrombosis; 7. Concomitant medical problems such as uncontrolled hypertention, severe cardiovascular disorder, chronic obstructive pulmonary disease, liver or renal failure; 8. allergic to dexamethasone; 9. Using adrenal cortical hormone in recent sit months 

研究实施时间:

Study execute time:

From2016-01-31To 2016-05-15 

干预措施:

Interventions:

组别:

A

样本量:

50

Group:

High-dose group

Sample size:

干预措施:

高剂量地塞米松(术前10 mg,术后4h 20mg)

干预措施代码:

Intervention:

Dexamethasone administered 10 mg before surgery followed by 20 mg appropriate 4 hours after surgery

Intervention code:

组别:

B

样本量:

50

Group:

Multi-dose group

Sample size:

干预措施:

多剂量地塞米松(术前10 mg,术后4h 10mg,术后20h 10mg)

干预措施代码:

Intervention:

Dexamethasone administered 10 mg before surgery followed by 10 mg 4 h and 20 h after surgery

Intervention code:

组别:

C

样本量:

50

Group:

Low-dose group

Sample size:

干预措施:

低剂量地塞米松(术前10 mg,术后4 h 10mg)

干预措施代码:

Intervention:

Dexamethasone administered 10 mg before surgery followed by 10 mg 4 h after surgery

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川 

市(区县):

成都 

Country:

China 

Province:

Sichuan 

City:

Chengdu 

单位(医院):

华西医院 

单位级别:

三甲 

Institution
hospital:

West China Hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

疼痛评分

指标类型:

主要指标 

Outcome:

VAS (0-100)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

炎性指标

指标类型:

次要指标 

Outcome:

Inflammatory indicators (ESR, CRP, IL-6)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

输血量

指标类型:

次要指标 

Outcome:

Blood transfusion volume

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

输血率

指标类型:

次要指标 

Outcome:

Blood transfusion cases

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血红蛋白量

指标类型:

次要指标 

Outcome:

Hb

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

红细胞压积

指标类型:

次要指标 

Outcome:

Hct

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

住院时间

指标类型:

次要指标 

Outcome:

Length of hospital stay

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

满意度

指标类型:

次要指标 

Outcome:

Satisfaction

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

膝关节功能量表

指标类型:

次要指标 

Outcome:

KOOS

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

伸膝肌力

指标类型:

次要指标 

Outcome:

Knee-extension strength

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

髋关节功能量表

指标类型:

次要指标 

Outcome:

HOOS

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肌力评分

指标类型:

次要指标 

Outcome:

5-scale musle score

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

HSS

指标类型:

次要指标 

Outcome:

HSS

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

KSS

指标类型:

次要指标 

Outcome:

KSS

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

短期并发症

指标类型:

次要指标 

Outcome:

Short-term Complications (SSI)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

长期并发症

指标类型:

次要指标 

Outcome:

Long-term Complications (Infection)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

Blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 22 years
最大 Max age 72 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

由工作人员运用电脑随机数字产生随机序列

Randomization Procedure (please state who generates the random number sequence and by what method):

Using computer-generated random number table to generate a random sequence by worker

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Real time access

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

华西医院

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

West China Hospital

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

华西医院

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

West China Hospital

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2016-01-30
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